US FDA Issues Warning Against Using Smartwatches, Smart Rings to Measure Blood Sugar

The US Food and Drug Administration (FDA) has issued a warning against the use of smartwatches and rings that claim to measure blood sugar levels without piercing the skin.

This alert, issued on February 22, 2024, targets devices from any brand that asserts the capability to monitor blood glucose levels noninvasively. To date, the FDA has not authorized any device of this nature for medical purposes.

Why is the FDA's Warning Important?

The advisory does not extend to smartwatch applications that are connected to sensors for continuous glucose monitoring systems, which directly measure blood sugar levels.

These systems are crucial for the approximately 37 million Americans living with diabetes-a condition characterized by the body's inability to properly regulate blood sugar due to insufficient insulin production or resistance to insulin.

Traditional management of diabetes involves regular monitoring of blood sugar levels, either through finger prick blood tests or sensor-based continuous glucose monitoring systems.

Risk to Diabetic Patients

The concern with unapproved devices is the risk of inaccurate blood sugar readings, which, according to Dr. Robert Gabbay of the American Diabetes Association, could have "potentially devastating" consequences. Incorrect readings could lead to inappropriate medication dosages, risking severe health outcomes such as mental confusion, coma, or death.

Dr. David Klonoff, with 25 years of research in diabetes technology at the Sutter Health Mills-Peninsula Medical Center in San Mateo, California, noted that several companies are attempting to develop noninvasive blood sugar measuring devices. However, none have yet achieved the accuracy and security necessary for FDA approval.

According to Klonoff, the technology used in smartwatches and rings for measuring other health metrics like heart rate and blood oxygen levels falls short in accurately measuring blood sugar. Research into noninvasive measurement through body fluids such as tears, sweat, and saliva also remains inconclusive.

Importance of Regulatory Approval

Klonoff remains optimistic that a solution will emerge, but in the meantime, advises consumers seeking accurate blood sugar measurements to opt for FDA-cleared blood glucose monitors available at pharmacies. He emphasizes that using FDA-approved products significantly reduces health risks compared to unapproved alternatives.

This warning from the FDA serves as a crucial reminder for individuals with diabetes and the wider public to be cautious of unverified medical devices and underscores the importance of regulatory approval in ensuring the safety and efficacy of health monitoring technology.

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